The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed Sof-serter Infusion Set Insertion System, Model 300.
| Device ID | K970479 |
| 510k Number | K970479 |
| Device Name: | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 |
| Classification | Introducer, Syringe Needle |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Don Selvey |
| Correspondent | Don Selvey MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-07 |
| Decision Date | 1997-03-31 |
| Summary: | summary |